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CompletedNCT02113137Updated Apr 14, 2014

Oral Hygiene Procedures on Reduction of Oral Malodor

A Phase 4 interventional study of group 1: drug: chlorine dioxide and group 2: device: small tooth brush for tongue cleaning in Halitosis, sponsored by Ei Ei Aung. Completed at 1 site in Japan. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-14.

Sponsored by Ei Ei Aung · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study summary

The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.

Read the detailed description

Thirty volunteers who matched with including criteria were divided randomly into two groups. Both groups were instructed to brush their teeth with a scrubbing method for the first one week. Then, each group received the different additional oral malodor reduction regimen- in addition to tooth brushing tongue cleaning in one group and chlorine dioxide (ClO2) mouthwash in another group for three consecutive weeks. After that, all the participants were instructed to practice all the three oral hygiene procedures (tooth brushing, mouth washing, tongue cleaning) the last one week. Total volatile sulfur compounds (VSCs) measured by breathtron, tongue coating, plaque score and bleeding on probing (BOP) were outcomes of this study.

02

Conditions studied

  • Halitosis

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Keywords

  • halitosis
  • chlorine dioxide
  • tongue cleaning
03

In context

Halitosis

88 studies on the registry are indexed under Halitosis; 18 are open to participants now.

This study's enrollment of 30 is below the median of 45 across 75 interventional studies indexed under Halitosis.

Browse Halitosis studies →

Lead sponsor

This is the only study on the registry with Ei Ei Aung as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Clinical diagnosis of oral malodor
  • At least 20 functional teeth
  • No systemic diseases
  • No severe dental diseases

Exclusion criteria

Exclusion Criteria:

  • Habit of smoking and betel quid chewing
  • Oral malodor by food and other craniofacial abnormalities
  • Current use of any kind of mouthwash
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    group 1: drug

    Drug: group 1: drug: chlorine dioxide 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks

    Drug: group 1: drug: chlorine dioxide

  • Experimental
    group 2: device:

    group 2: device: small tooth brush for tongue cleaning small tooth brush for tongue cleaning

    Device: group 2: device: small tooth brush for tongue cleaning

Interventions

  • Druggroup 1: drug: chlorine dioxide

    First, each group practiced tooth brushing only for one week. After that each group was requested to do the following procedures. group 1 - additional use of 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks besides tooth brushing. At last, each group practiced all three methods of tooth brushing, tongue cleaning, mouth washing.

    Also known as: ClO2Fresh®

  • Devicegroup 2: device: small tooth brush for tongue cleaning

    First, each group practiced tooth brushing only for one week. After that each group was requested to do the following procedures. group 2 - additional practice of tongue cleaning by a small tooth brush two times per day, for three consecutive weeks besides tooth brushing. At last, each group practiced all three methods of tooth brushing, tongue cleaning, mouth washing.

06

What researchers measure

Primary outcomes

  1. Volatile sulfur compounds (VSCs)

    Total volatile sulfur compounds was measured by Breathron®

    Time frame: 5 weeks

Secondary outcomes

  1. Bleeding on probing

    gingival bleeding was recorded of bleeding was detected after examination with periodontal probe.

    Time frame: 5 weeks

  2. Tongue coating

    tongue coating was evaluated by Winkel tongue coating index.

    Time frame: 5weeks

  3. Debris index

    debris index was evaluated by oral hygiene index.

    Time frame: 5 weeks

07

Study locations

1 site
  • Department of oral health promotion
    Tokyo, 113-8549, Japan
08

References and documents

Publications

  • Aung EE, Ueno M, Zaitsu T, Furukawa S, Kawaguchi Y. Effectiveness of three oral hygiene regimens on oral malodor reduction: a randomized clinical trial. Trials. 2015 Jan 27;16:31. doi: 10.1186/s13063-015-0549-9. PubMed 25622725 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02113137
Lead sponsor
Ei Ei Aung
Responsible party
Ei Ei Aung (Graduate student, department of oral health promotion, Tokyo Medical and Dental University) — Sponsor-investigator
First posted
Apr 14, 2014
Start date
Sep 2013
Primary completion
Oct 2013
Completion
Nov 2013
Last update
Apr 14, 2014

Study contacts

EiEi Aung, student
principal investigator · Department of oral health promotion

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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